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GenomeWeb - Cancer Patient Groups Urge Oregon Committee to Soften Non-Coverage Stance on NGS Panels

A negative coverage recommendation proposed by the Oregon Health Authority could restrict access to next-generation sequencing tumor profiling for some of the most vulnerable residents in the state, cancer patient advocates fear.


Pink Sheet - Guidance By Guidance, US FDA Is Reshaping The Look Of Cancer Drug Trials

Executive Summary

Recent draft guidance documents address adolescent enrollment in adult cancer trials, use of cohort designs in early-phase studies, and inclusion of placebo controls; more advice is coming soon on master protocols, adaptive designs and novel endpoints, FDA's Gottlieb says.


The US FDA is using its guidance-writing powers to reshape the look of oncology clinical trials, with the goal of streamlining and modernizing cancer drug development in order to foster a more patient-focused approach.


Pink Sheet - “One Continuous Trial” In Oncology: US FDA Offers Guidance And Encouragement

Executive Summary

One of the hallmarks of the “breakthrough” era has been the rapid expansion of first-in-human trials into pivotal studies for efficacy submissions. In a new draft guidance, FDA offers some initial thoughts on safeguards to make hyperfast development pathways successful.


A US FDA draft guidance on expansion cohorts serves as a “starting point” memorandum to drug sponsors on how first-in-human (FIH) trials can be expanded and adapted to turn into pivotal trials to support a new drug application.


MedTech Insight - Clinical Labs Find Fault In FDA Dx Reform Ideas, But Kit-Makers Signal General Approval

Executive Summary

The American Clinical Laboratory Association (ACLA) split with other stakeholder groups in criticizing US FDA’s proposals for a new diagnostics regulatory regime. ACLA asked Congress to stay closer to Reps. Diana DeGette's and Larry Bucshon’s original Diagnostics Accuracy and Innovation Act draft bill language.

Pink Sheet - Real-World Evidence Challenges: Death Among Toughest Data Points To Measure

Executive Summary

Death typically is not included in electronic health records, and sources are disparate; Difficulties with endpoint expose potential limitation to real-world evidence use.


Death, likely among the easiest real-world data points to measure, is proving among the more difficult to gather, illustrating that while real-world data holds great promise, there still are fundamental hurdles to overcome before its widespread use.


The ASCO Post - Real-World Evidence Gaining Credibility and Practicality in Treatment Evaluation

In a Friends of Cancer Research (Friends) meeting devoted to real-world evidence, members of the cancer community generally agreed that its use has an increasingly important role to play in gathering the data necessary to test, evaluate, and bring new therapeutic agents to market. This Friends meeting, which was titled “The Future Use of Real-World Evidence,” was held in July in Washington, DC.

Healio - Strict cancer trial eligibility criteria ensure patient safety, but ‘pendulum has swung too far’

Clinical trials are the cornerstone of oncology research.


Despite their essential role in evidence-based medicine, enrollment barriers are more formidable than ever.

Limited study availability at some academic and community centers, as well as lack of provider recommendation, largely explain why fewer than one in 20 patients with cancer participate in clinical trials.


Inside Health Policy - FDA Draft Guide Recommends Seamless Trials For Drugs That Fulfill Unmet Clinical Need, Treat Pediatric Cancers

FDA issued draft guidance Friday (Aug. 10) intended to help streamline the drug development process for cancer drugs and biological products by providing sponsors with advice on how they can design and conduct seamless clinical trials, which allow drug developers to conduct one continuous trial and avoid the stops and starts associated with traditional three-phase trials.


Cancer Today - August 10: The Week in Cancer News

No more than 5 percent of cancer patients enroll in clinical trials. Many patient advocates say restrictive eligibility criteria prevent people who want to be part of research from participating. On Aug. 9, the American Society of Clinical Oncology and Friends of Cancer Research submitted draft guidance documents​ to the U.S. Food and Drug Administration for broadening eligibility criteria.

Inside Health Policy - FDA Floats Lab Test Oversight Bill Revisions; Device Makers, Clinical Labs Praise Proposal

Following years of debate on the issue, FDA is floating a legislative proposal that would cement the agency's authority to regulate high-risk clinical laboratory diagnostics – including laboratory-developed tests and in-vitro diagnostics – under a risk-based framework in which lower-risk tests could go through FDA's new, voluntary precertification pathway. The plan drew praise from device test manufacturers, clinical labs and patient advocates, who had been divided on what path FDA should take to regulate clinical lab tests that historically fell in CMS' turf.